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ChorioamnionitisPhase 4NCT03168178

Intrapartum Fever: Antibiotics Versus no Treatment

A Phase 4 study testing Standard Antibiotic Treatment and No Antibiotic Treatment in people with Chorioamnionitis and Intrapartum Fever, run by University of Utah at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine whether antibiotics can be safely avoided in women who develop a fever during labor. Because investigators have no accurate tests to determine whether women who develop fever during labor have intra-amniotic infection, antibiotics are often used to prevent spread of infection… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Standard Antibiotic Treatment and No Antibiotic Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
8 Jun 2017to 26 Jul 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant women between 34-42 weeks gestation
  • Singleton fetus
  • Admitted for labor management \& develops a fever of 100.4 F or greater

Who cannot join

  • Known fetal anomaly
  • Other indication for intrapartum antibiotics (endocarditis prophylaxis, other known maternal infection)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah, Department of Obstetrics & Gynecology

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: A Randomized Trial in Intrapartum Fever Of No Antibiotics for Low-risk Women (RATIONAL)

The purpose of this study is to determine whether antibiotics can be safely avoided in women who develop a fever during labor. Because investigators have no accurate tests to determine whether women who develop fever during labor have intra-amniotic infection, antibiotics are often used to prevent spread of infection to the fetus.

Read the detailed description

A fever > 100.4 F during labor (intrapartum fever) complicates up to 14% of term deliveries, and is commonly considered a sign of intrauterine infection. Despite studies showing that most causes of maternal intrapartum fever are non-infectious, intrapartum fever often prompts the diagnosis of chorioamnionitis/intrauterine infection, or what is now known as 'triple I' (intra-amniotic infection or inflammation). Diagnosis of triple I is primarily based on clinical findings such as maternal fever, maternal leukocytosis, uterine tenderness, foul-smelling or purulent amniotic fluid, and fetal tachycardia. A minimum of two of these criteria for diagnosis, although this distinction is somewhat artificial as fetal tachycardia is highly associated with maternal fever. The poor performance of clinical signs and lack of effective biomarkers to identify neonatal infection results in over treatment of both mothers and infants.

Avoiding antibiotic use in mothers and infants is desirable in order to avoid unnecessary separation after birth, decreasing cost and interventions in newborns, and to avoid altering the infant's microbiome (the bacteria newborns carry on their skin, mucosal membranes, and in their gut at the time of birth). Infants with altered microbiomes may be at risk for skin, pulmonary, and gastrointestinal disorders. The investigators in this trial are randomizing women with fever during labor who are felt to be a low risk for true infection to antibiotic treatment compared to no antibiotics in order to determine if antibiotics can be safely avoided for these women and their infants.

Being tested
Standard Antibiotic Treatment, No Antibiotic Treatment
Medical subject headings
Chorioamnionitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Antibiotic TreatmentDrug

    Participants randomized to this intervention will receive standard antibiotic treatment.

    The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes

  • No Antibiotic TreatmentOther

    Participant randomized to this arm of the study will not receive antibiotics. The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes

Study groups in NCT03168178
Study groupRoleWhat they receive
Standard Antibiotic TreatmentActive comparatorStandard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Receives: Drug: Standard Antibiotic Treatment
No Antibiotic TreatmentExperimentalNo Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.
Receives: Other: No Antibiotic Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator.

    All newborns will have a screening assessment including physical exam and vital signs, and this data along with maternal and delivery data is entered into the Kaiser Permanente Early Onset Neonatal Sepsis (EONS) calculator. The EONS calculator estimates the risk of sepsis and recommends observation, additional evaluation, or empiric antibiotic treatment.

    Measured: Within 2 hours of delivery

Secondary outcomes (7)

  1. Positive blood culture

    For infants who have a blood culture obtained by recommendation of the EONS calculator, the presence of significant bacterial growth will be considered a positive culture.

    Measured: Up to 4 days after birth

  2. Need for NICU admission

    Admission of the infant to the Newborn Intensive Care Unit

    Measured: Up to 4 weeks after birth

  3. Newborn length of stay

    Days hospitalized after birth

    Measured: Up to 4 weeks after birth

  4. Maternal endometritis

    The diagnosis of endometritis made by the patient's OB provider requiring treatment with antibiotics.

    Measured: Up to 4 weeks after birth

  5. Maternal length of stay

    Days hospitalized after delivery

    Measured: Up to 4 weeks after birth

  6. Patient satisfaction

    Satisfaction with maternal and newborn care using a standardized survey administered by phone at 6-8 weeks after delivery

    Measured: 6-8 weeks after delivery

  7. Cost

    The hospital charges for mother and infant

    Measured: Up to 4 weeks after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start8 Jun 2017
  3. Primary completion26 Jul 2018
  4. Study completion26 Jul 2018

Why it stopped: Participant enrollment was much more challenging than anticipated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Low risk women will be randomized to standard antibiotic treatment versus no antiobiotics.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168178
Sponsor's protocol ID
91955
Status last verified
Oct 2018
First submitted
18 May 2017
Last updated
23 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smulian JC, Bhandari V, Vintzileos AM, Shen-Schwarz S, Quashie C, Lai-Lin YL, Ananth CV. Intrapartum fever at term: serum and histologic markers of inflammation. Am J Obstet Gynecol. 2003 Jan;188(1):269-74. doi: 10.1067/mob.2003.11.

    PubMed 12548228

  • Smulian JC, Shen-Schwarz S, Vintzileos AM, Lake MF, Ananth CV. Clinical chorioamnionitis and histologic placental inflammation. Obstet Gynecol. 1999 Dec;94(6):1000-5. doi: 10.1016/s0029-7844(99)00416-0.

    PubMed 10576190

  • Roberts DJ, Celi AC, Riley LE, Onderdonk AB, Boyd TK, Johnson LC, Lieberman E. Acute histologic chorioamnionitis at term: nearly always noninfectious. PLoS One. 2012;7(3):e31819. doi: 10.1371/journal.pone.0031819. Epub 2012 Mar 7.

    PubMed 22412842

  • Taylor JA, Opel DJ. Choriophobia: a 1-act play. Pediatrics. 2012 Aug;130(2):342-6. doi: 10.1542/peds.2012-0106. Epub 2012 Jul 9.

    PubMed 22778303

  • Escobar GJ, Puopolo KM, Wi S, Turk BJ, Kuzniewicz MW, Walsh EM, Newman TB, Zupancic J, Lieberman E, Draper D. Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation. Pediatrics. 2014 Jan;133(1):30-6. doi: 10.1542/peds.2013-1689. Epub 2013 Dec 23.

    PubMed 24366992

  • Cuna A, Hakima L, Tseng YA, Fornier B, Islam S, Quintos-Alagheband ML, Khullar P, Weinberger B, Hanna N. Clinical dilemma of positive histologic chorioamnionitis in term newborn. Front Pediatr. 2014 Apr 4;2:27. doi: 10.3389/fped.2014.00027. eCollection 2014.

    PubMed 24772410

  • Evers AC, Nijhuis L, Koster MP, Bont LJ, Visser GH. Intrapartum fever at term: diagnostic markers to individualize the risk of fetal infection: a review. Obstet Gynecol Surv. 2012 Mar;67(3):187-200. doi: 10.1097/OGX.0b013e31824bb5f1.

    PubMed 22901952

  • Buhimschi IA, Christner R, Buhimschi CS. Proteomic biomarker analysis of amniotic fluid for identification of intra-amniotic inflammation. BJOG. 2005 Feb;112(2):173-81. doi: 10.1111/j.1471-0528.2004.00340.x.

    PubMed 15663581

  • Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.

    PubMed 21518717

  • Newman TB, Puopolo KM, Wi S, Draper D, Escobar GJ. Interpreting complete blood counts soon after birth in newborns at risk for sepsis. Pediatrics. 2010 Nov;126(5):903-9. doi: 10.1542/peds.2010-0935. Epub 2010 Oct 25.

    PubMed 20974782

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Standard Antibiotic Treatment and No Antibiotic Treatment in people with Chorioamnionitis and Intrapartum Fever, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator. (time frame: Within 2 hours of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03168178, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.

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